Status:
COMPLETED
A Comparison of Hyaluronic Acid and Estradiol Treatment in Vulvovaginal Atrophy.
Lead Sponsor:
Koru Health Groups
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
The goal of this observational study isto compare the effect hyaluronic acid and estradiol in vulvo-vaginal atrophy.Hyaluronic acid and Estrogen were equally effective in vaginal treatment. Hyaluronic...
Detailed Description
This randomized, controlled, monocentric, prospective, comparative (before/after) study was conducted at Koru Ankara Hospital between April 2023 and September 2023. Patients were randomized into 2 gro...
Eligibility Criteria
Inclusion
- \- age over 40 years, FSH value above 25 pg/ml, LH value above 20 pg/ml, E2 value below 15 pg/ml, endometrial thickness of 5 mm or less, and absence of menstruation for 12 months.
Exclusion
- patients receiving Hormone Replacement Therapy (HRT), genital organ malignancy, breast cancer, patients with vaginal bleeding of unknown cause, history of thrombophlebitis and thromboembolism, thrombophilia, acute or chronic cardiovascular diseases, estrogen and hyaluronic acid allergy, vaginal infection, acute or chronic cardiovascular diseases, and liver diseases. Patients eligible to participate in the study were required to report at least one of the following symptoms: vaginal dryness, burning or irritation, lack of lubrication during intercourse, sexual discomfort or pain during intercourse, dysuria, or recurrent urinary tract infection.
Key Trial Info
Start Date :
April 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06144814
Start Date
April 5 2023
End Date
September 30 2023
Last Update
November 22 2023
Active Locations (1)
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1
Turkey
Ankara, Çankaya, Turkey (Türkiye), 06530